BeiGene gains NMPA approval for new biologics facility in Guangzhou

Sino-American biotech firm BeiGene (Nasdaq: BGNE) today announced approval from the China National Medical Products Administration (NMPA) for BeiGene to begin manufacturing commercial supply of its approved anti-PD-1 antibody, tislelizumab, at its state-of-the-art biologics facility in Guangzhou, China.

At over one million square feet (100,000 square meters) and 8,000 liters of biologics capacity approved for commercial supply, this wholly-owned facility will immediately begin production of commercial supply of tislelizumab for the China market. An additional phase of construction currently in progress to bring total capacity to 64,000 liters is expected to be completed by the end of 2022.

“We started building this large-scale, commercial biologics manufacturing facility in 2017 to meet our expected future demand. Since that time, tislelizumab has been approved in several indications in China, included in the National Reimbursement Drug List (NRDL), and licensed to Novartis in Europe, North America, and Japan,” commented Xiaobin Wu, president, chief operating officer and general manager of China at BeiGene.